Investigating red light therapy in managing post operative pain after dental extractions

Objective: Compare the efficacy of post operative pain after dental extractions with a multiwavelength light emitting diode (LED) device (Nuralyte®, Dentroid Canberra, Australia) to sham exposure. Intervention: Participants will be attending a dental appointment for a dental extraction (simple or surgical). They will then be randomly chosen to receive either a light emitting diode with the Nuralyte® device for 2-4 minutes or a placebo (inactive light). After the dental extraction, they will be asked to report the level of discomfort on days 2,3,4 via mobile text message. • Group 1: Placebo – 1 minute buccal and 1 minute lingual of socket = 2min total • Group 2: Blend mode - 1 minute buccal and 1 minute lingual of socket = 2min total • Group 3: Boost mode - 2 minute buccal and 2 minute lingual of socket = 4min total This study will test the effects on post-operative pain of two different light wavelengths from the LED array in the Nuralyte. The device uses a custom-build LED array that has 4 separate LED emitters (700, 850, 970 and 1050 nm). The spectral width of the emitted light from each of these emitters is as follows (40 nm width, 60 nm width, 160 nm width, 100 nm width). The first of the light wavelengths to be tested is 1050 nm. This wavelength is very similar to that of the Nd:YAG ( neodymium-doped yttrium aluminum garnet; Nd:Y3Al5O12) laser (1064 nm), which has known analgesic actions when used for treating pain. For this, the Nuralyte will be used in "Boost" mode, where only the 1050 nm LED light is powered. This 1010 nm LED emitter delivers an optical power of 300 mW. An exposure time of 60 seconds will give a delivered dose to the site of 18 Joules. The second setting is to use all 4 different light wavelengths in combination (i.e. 700, 850, and 970 nm as well as 1050 nm). The rationale here is that each of the 3 shorter wavelengths also can contribute to analgesic pain-relieving actions. For this, the Nuralyte will be used in "Blend" mode, where all 4 LEDs operate simultaneously to deliver light from the device. When all 4 LEDs operate, the total combined optical power of is 1000 mW (i.e. 300 mW from 1050 nm, plus a total of 700 mW from the 3 other LEDs). As the total power is greater in Blend mode than Boost mode, the exposure time on Blend mode will be only 20 seconds rather than 60 seconds, so that the delivered dose to the treated site remains comparable, at 20 Joules. Who will deliver the intervention This trial will be undertaken by a registered general dentist or dental specialist. The intervention will administered in a clinical setting utilising appropriate personal protective equipment and following manufacturer instructions. Location where intervention will occur The study will occur at private practice dental clinics in Queensland, Australia (multi-centre study). Participant selection Adult dental patients (aged 18 years and above) who require a dental extraction as part of routine dental treatment will be invited to participate in the study. The registered dental practitioner or registered dental specialist will screen the patient and those who adhere to the inclusion criteria will be invited to participate. Mode of delivery/number of times delivered Each participant will be randomly selected to receive application of either sham exposure or the Nuralyte® device immediately after the completion of the dental extraction. The registered general dental practitioner or dental specialist will also be required to record the following parameters at the time of the appointment on the provided data collection sheet: • Tooth of interest (Federeal dental international notation), patient age and gender • Type of extraction – simple, sectional, surgical (311,314,322,324) • If flap was raised, if bone was removed • Pell & Gregory classification if lower 3rd molar • Approximate time of procedure • Local anaesthetic given and amount given • Clinician rating complexity of procedure • If performed under local anaesthetic, nitrous, intravenous sedation or general anaesthetic • Dentist name and clinic location • Patient mobile number • Reported visual analogue (VAS) pain scale for adult participants (score 1-10) on days 2,3,4